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An important new bill that would give the federal government powers to recall dangerous medications contains several surprising loopholes, according to a group of drug safety researchers and experts in health law.

In an article published Monday in the Canadian Medical Association Journal, the group argues that Bill C-17 “by no means offers a comprehensive solution to the many problems that have plagued the development, regulation and safe use of prescription drugs.”

The bill, potentially the first update to patient safety legislation in decades, shows a “lack of attention to transparency,” said lead author Matthew Herder, assistant professor at Dalhousie University’s Faculty of Medicine.

“It’s surprising and it’s a problem.”

Herder and his colleagues say Health Canada must add several “critical elements” if it is to fulfill its goal of protecting patients.

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For instance, the proposed recall power should apply not only to those who sell the products, they say. There are now many players in the drug production and distribution chain, and Health Canada’s powers should extend to all of them to ensure problem drugs are quickly and fully removed from the market.

In the early 1960s, when thalidomide, a morning sickness drug, was found to be causing severe deformities in babies, manufacturers eventually withdrew the drug after some negotiation with Health Canada. But free samples, the primary form of the drug’s distribution, were still sitting in doctor’s offices across the country. Health Canada’s Food and Drug directorate had no legal authority to control or contain this problem.

A 1962 amendment to the Food and Drugs Act allowed the distribution of drug samples only under “prescribed conditions” but failed to grant the government legal authority to unilaterally recall drugs.

The new bill must also clearly exempt the health minister from liability when a drug suspension or recall is issued by government, Herder says. Without this protection, there is a “strong disincentive” to invoking the power to suspend or recall a drug, he points out.

The last attempt to improve patient safety legislation, through Bill C-51, died on the order paper in 2008.

In that incarnation, the proposed law included a clause to improve the transparency of drug safety information and ensure that the public could gain access to this data.

This kind of language does not exist in Bill C-17, and it should, Herder said.

Health Canada has been criticized for failing to disclose basic safety data.

Last year, the department issued a statement assuring the public that a popular acne drug used widely off-label as birth control was safe, despite its connection to the deaths of at least 13 young women, many of them teenagers.

Health Canada said it conducted a safety review of the drug but refused to release the report, claiming it contained confidential business information. The department has been shielding hundreds of other drug safety reviews with the same argument.

After a series of articles on this issue appeared in the Toronto Star last fall, federal health minister Rona Ambrose quickly promised to make these reports public.

Five months later, the public is still waiting.

Herder and his colleagues say Bill C-17 needs to clearly outline what is and isn’t “confidential business information.”

Untested assertions about trade secrets prevent important safety information from being released.

“No Canadian court decision indicates that information about the safety or efficacy of a drug is proprietary, and current case law casts doubt on any such assertion,” the paper states.

The CMAJ article says Health Canada needs to go a step further to ensure that clinical trial data on new drugs, guarded closely by many companies, can be publicly scrutinized. There should be no doubt in the law that the results of these trials, including post-market studies and adverse drug reactions reported by manufacturers and health-care institutions, are not proprietary.

Health Minister Ambrose’s office declined to comment on the specific recommendations outlined by Herder and his colleagues.

“We look forward to a fulsome debate in Parliament and passing this bill, which represents the first update to patient safety legislation in decades,” said spokesman Michael Bolkenius.

The bill has been tabled and it is scheduled for the first hour of debate on March 28.

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